Recall Register

Food, drugs, devices › Firms

American Contract Systems Inc

FDA recalling firm · 22 enforcement events · 196 product records · 2016–2026 · MO, OH

American Contract Systems Inc has 22 FDA enforcement events on this register (196 product records) between 2016 and 2026: 22 device; the busiest year was 2025 with 6.

9% of its events are Class I; the most common class is Class II (19). 19 events are listed as ongoing; the recalling firm's address is in MO and OH.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
29 Jun 2026American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMDeviceClass II4Ongoing
19 May 2026American 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 MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number…DeviceClass II2Ongoing
19 Mar 2026Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQDeviceClass I1Ongoing
4 Sep 2025Basic Biopsy Tray, Item Number NMBP44LDeviceClass II18Ongoing
14 Jul 2025AMERICAN 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, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5) PEDIATRIC OPEN…DeviceClass II9Ongoing
21 Apr 2025LOWER 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: QTX30-322NSDeviceClass II1Ongoing
6 Feb 2025LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41GDeviceClass II32Ongoing
4 Feb 2025CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.DeviceClass II1Ongoing
31 Jan 2025Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: NoDeviceClass II3Ongoing
7 Aug 2024PACEMAKER PACK, SLCV01J; Medical convenience kitDeviceClass II19Ongoing
15 May 2024AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50KDeviceClass II39Ongoing
6 May 2024American Contract Systems Hand Pack convenience kitDeviceClass II8Ongoing
29 Nov 2023Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43LDeviceClass II18Ongoing
1 Sep 2023General Pack, REF BBGP31CDeviceClass II12Ongoing
17 Apr 2023Total Knee Pack, REF CETJ130, medical convenience kitsDeviceClass III1Ongoing
12 Oct 2022BASIN SET, MEBS42K, general surgical kitDeviceClass II1Terminated
12 Aug 2022COVID Test Kit NonsterileDeviceClass II1Ongoing
16 Jun 2022Various Angiography packs/traysDeviceClass II17Ongoing
2 May 2022Clean Catch Urine Kit NS 178489, AHMU58ADeviceClass I2Ongoing
22 Mar 20221) ACS Spine Pack 2) ACS Lumbar/Back Set Up TrayDeviceClass II5Ongoing
21 Nov 2018Bag 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 - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE; d. Tray…DeviceClass II1Terminated
28 Dec 2016Powdered 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 barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when…DeviceClass II1Terminated

By type and class

Device22
Class II19
Class I2
Class III1

Class I: 9% of this firm's events; 18% of all events on the register.

Events by year

16
17
18
19
20
21
22
23
24
25
26
Enforcement events for American Contract Systems Inc by year initiated.

Questions and answers

How many FDA recalls has American Contract Systems Inc had?

22 enforcement events (196 product records) on this register, 2016–2026: 22 device.

Are any American Contract Systems Inc recalls ongoing?

19 events are listed as ongoing in the current openFDA export.

What class are American Contract Systems Inc recalls?

19 Class II, 2 Class I, 1 Class III. 9% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.