Tiffin, OH, United States
American Contract Systems Inc recalls
24 recalls recorded since 2018, most recently on 10 August 2026. 20 are listed as ongoing. Status and classification are as published by the FDA.
Recalls24
Ongoing (FDA)20
Terminated or completed4
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 10 August 2026
- Reason
- Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
- Distribution
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3294-2026, Z-3293-2026, Z-3292-2026
- Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Mode
- Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿ 0248495 Model No. RCOH62C
- Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
Ongoing Class II Medical devices
- Recall started
- 29 June 2026
- Reason
- The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
- Distribution
- US Nationwide distribution in the states of IA, OH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3003-2026, Z-3001-2026, Z-3000-2026, Z-3002-2026
- American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
- American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AN
- American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AM
- American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Ongoing Class II Medical devices
- Recall started
- 19 May 2026
- Reason
- The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Distribution
- US distribution to states of: MN, MO, IA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2990-2026, Z-2989-2026
- American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
- American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHC
Ongoing Class I Medical devices
- Recall started
- 19 March 2026
- Reason
- Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
- Distribution
- US distribution to MN. No OUS distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1981-2026
- Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Ongoing Class II Medical devices
- Recall started
- 4 September 2025
- Reason
- Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
- Distribution
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0180-2026, Z-0185-2026, Z-0174-2026, Z-0173-2026, Z-0187-2026, Z-0170-2026, Z-0184-2026, Z-0171-2026, Z-0186-2026, Z-0182-2026, Z-0175-2026, Z-0181-2026 and 6 more
- Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224
- Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PAC
- Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO P
- Medical convenience kits Item number/ Product description AHLD15X LABOR DELIVERY PACK - 213387 AKDV96B VAGINAL DELIVERY AKDV96B VAGINAL DELIVERY EVBH28D BIRTHING ROOM PACK UPVD01K VAGINAL DELIVERY PACK
- Medical convenience kits IHDC30R D AND C PACK
- Basic Biopsy Tray, Item Number NMBP44L
- Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP AC
- Basic Biopsy Tray; Item Number/Description: AKRB26D ROBOTIC, AMGL09AA GENERAL LAPAROSCOPY, ANLC35AD LAP CHOLE PACK - 205956, ANLP25AJ LAPROSCOPY PACK - 205958, FYLA38E LAPCHOLAPPY PACK, IHDA88AH DIVINCI GYN
- and 10 more product lines
Ongoing Class II Medical devices
- Recall started
- 14 July 2025
- Reason
- During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Distribution
- US distribution to states of: IL and LA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2472-2025, Z-2469-2025, Z-2468-2025, Z-2464-2025, Z-2467-2025, Z-2465-2025, Z-2470-2025, Z-2466-2025, Z-2471-2025
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HS
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MO
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PA
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK,
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 21 April 2025
- Reason
- Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.
- Distribution
- US Nationwide distribution in the state of CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1916-2025
- LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
Ongoing Class II Medical devices
- Recall started
- 6 February 2025
- Reason
- ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
- Distribution
- US Nationwide distribution in the state of OH.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1358-2025, Z-1338-2025, Z-1343-2025, Z-1357-2025, Z-1336-2025, Z-1354-2025, Z-1348-2025, Z-1339-2025, Z-1333-2025, Z-1350-2025, Z-1352-2025, Z-1346-2025 and 20 more
- MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
- LABOR & DELIVERY PACK, Model Nos LLLD19H
- CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
- GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
- C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
- DIAGNOSTIC NEURO IR TRAY , Model No WENE21
- DELIVERY PACK , Model No SGDV22D-01 SGDV22E
- OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
- and 24 more product lines
Ongoing Class II Medical devices
- Recall started
- 4 February 2025
- Reason
- During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
- Distribution
- US: MI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1406-2025
- CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Ongoing Class II Medical devices
- Recall started
- 31 January 2025
- Reason
- Sterility assurance with procedure trays
- Distribution
- US: AZ OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1426-2025, Z-1424-2025, Z-1425-2025
- Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No
- Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No
- Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
Ongoing Class II Medical devices
- Recall started
- 7 August 2024
- Reason
- ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Distribution
- US Nationwide distribution in the states of MO, MN, MA, OH, NE.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3244-2024, Z-3237-2024, Z-3238-2024, Z-3235-2024, Z-3242-2024, Z-3226-2024, Z-3236-2024, Z-3233-2024, Z-3234-2024, Z-3239-2024, Z-3227-2024, Z-3232-2024 and 7 more
- Pacemaker, COPM11B; Medical convenience kit
- Hand Pack, AKHD97C; Medical convenience kit
- Vaginal Delivery, ASDV25B; Medical convenience kit
- IR Procedure Pack, CEAT19W; Medical convenience kit
- Nasal Sinus Pack, MTSN26B; Medical convenience kit
- PACEMAKER PACK, SLCV01J; Medical convenience kit
- Neuro Vascular, ANKV91A; Medical convenience kit
- Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
- and 11 more product lines
Ongoing Class II Medical devices
- Recall started
- 15 May 2024
- Reason
- Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2275-2024, Z-2288-2024, Z-2310-2024, Z-2280-2024, Z-2281-2024, Z-2305-2024, Z-2311-2024, Z-2301-2024, Z-2292-2024, Z-2279-2024, Z-2300-2024, Z-2287-2024 and 27 more
- TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
- UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
- HAND PACK-Procedure Kit Catalog Number: WEHD16B
- ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
- ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C
- TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
- HAND PACK-Procedure Kit Catalog Number: WEHD16C
- KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
- and 31 more product lines
Ongoing Class II Medical devices
- Recall started
- 6 May 2024
- Reason
- Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
- Distribution
- US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2524-2024, Z-2517-2024, Z-2523-2024, Z-2519-2024, Z-2520-2024, Z-2522-2024, Z-2521-2024, Z-2518-2024
- American Contract Systems Spine Pack convenience kit
- American Contract Systems Hand Pack convenience kit
- American Contract Systems Biopsy Drape Pack convenience kit
- American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
- American Contract Systems Special Procedure Pack convenience kit
- American Contract Systems Cataract Pack convenience kit
- American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
- American Contract Systems Gyn Laparoscopy convenience kit
Ongoing Class II Medical devices
- Recall started
- 29 November 2023
- Reason
- During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0818-2024, Z-0820-2024, Z-0831-2024, Z-0819-2024, Z-0825-2024, Z-0822-2024, Z-0826-2024, Z-0828-2024, Z-0830-2024, Z-0817-2024, Z-0827-2024, Z-0821-2024 and 6 more
- Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULA
- Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
- Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
- Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Inser
- Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC
- Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, k
- Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pedia
- Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit
- and 10 more product lines
Ongoing Class II Medical devices
- Recall started
- 1 September 2023
- Reason
- During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.
- Distribution
- US Nationwide distribution in the states of FL, IA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0172-2024, Z-0174-2024, Z-0178-2024, Z-0177-2024, Z-0175-2024, Z-0176-2024, Z-0182-2024, Z-0179-2024, Z-0180-2024, Z-0173-2024, Z-0181-2024, Z-0171-2024
- LAVH, REF BBLV21C
- Robotics Pack SAH, REF SAR530M
- Robotics Pack, REF SJVO56B
- Vasc. Open CVOR SJH, REF SJVO56B
- CVS PCSU SJH, REF SJCV48J
- Pediatric Heart SJH, REF SJPH34K
- Cath Cardiac Pack, REF IHCC03V
- Robotics Pack, REF SSRO22D
- and 4 more product lines
Ongoing Class III Medical devices
- Recall started
- 17 April 2023
- Reason
- Incorrect expiration date on product.
- Distribution
- US Distribution to the state of: MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1973-2023
- Total Knee Pack, REF CETJ130, medical convenience kits
Terminated Class II Medical devices
- Recall started
- 12 October 2022
- Terminated
- 6 March 2025
- Reason
- Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0274-2023
- BASIN SET, MEBS42K, general surgical kit
Ongoing Class II Medical devices
- Recall started
- 12 August 2022
- Reason
- Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
- Distribution
- Distribution to one customer in PA only
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0071-2023
- COVID Test Kit Nonsterile
Ongoing Class II Medical devices
- Recall started
- 16 June 2022
- Reason
- Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- Distribution
- Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1689-2022, Z-1697-2022, Z-1703-2022, Z-1698-2022, Z-1699-2022, Z-1704-2022, Z-1696-2022, Z-1701-2022, Z-1705-2022, Z-1700-2022, Z-1691-2022, Z-1693-2022 and 5 more
- Various Angiography packs/trays
- Breast Abdominoplasty Pack
- Various C-section packs
- Various convenience packs
- Various convenience packs
- D&C pack
- Various Port Insertion Packs
- Various ob/gyn packs
- and 9 more product lines
Ongoing Class I Medical devices
- Recall started
- 2 May 2022
- Reason
- Affected products were assembled off-site by individuals who may not have been properly trained.
- Distribution
- US distribution in the state of Minnesota.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1276-2022, Z-1277-2022
- Clean Catch Urine Kit NS 178489, AHMU58A
- Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Ongoing Class II Medical devices
- Recall started
- 22 March 2022
- Reason
- Product was sterilized with a higher than specification EO concentration.
- Distribution
- US Nationwide distribution in the states of IL, MO, NE, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1040-2022, Z-1039-2022, Z-1036-2022, Z-1037-2022, Z-1038-2022
- ACS Cath Lab Pack
- ACS Lap Chole Pack
- 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
- 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
- ACS IR - Angio Pack
Terminated Class II Medical devices
- Recall started
- 13 April 2020
- Terminated
- 25 November 2020
- Reason
- The surgical gowns were manufactured in a facility that is not registered by the FDA.
- Distribution
- US Nationwide distribution including in the state of Pennsylvania.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2176-2020, Z-2175-2020, Z-2177-2020, Z-2178-2020, Z-2170-2020, Z-2172-2020, Z-2173-2020, Z-2169-2020, Z-2168-2020, Z-2166-2020, Z-2174-2020, Z-2171-2020 and 2 more
- Sterile Custom Packs to be used in surgical procedures.
- Sterile Custom Packs to be used in surgical procedures.
- Sterile Custom Packs to be used in surgical procedures.
- Sterile Custom Packs to be used in surgical procedures.
- Sterile Custom Packs to be used in surgical procedures.
- Sterile Custom Packs to be used in surgical procedures.
- Sterile Custom Packs to be used in surgical procedures.
- Sterile Custom Packs to be used in surgical procedures.
- and 6 more product lines
Terminated Class II Medical devices
- Recall started
- 21 November 2018
- Terminated
- 10 February 2021
- Reason
- Potential that product has not reached complete sterilization,
- Distribution
- US Distribution is to Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0964-2019
- Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH -
Terminated Class II Medical devices
- Recall started
- 28 December 2016
- Terminated
- 14 November 2018
- Reason
- Powdered Surgical Gloves are an FDA banned substance.
- Distribution
- US Distribution to states of: IL, MO, NE, and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0456-2019
- Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barr
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.