December 2022 recalls

608 recalls were announced in December 2022.

What the numbers show

Critical: 4
Severe: 99
High: 339
Moderate: 165
Low: 1

Of the 608 recalls this month scored against our rubric, 1% are Critical, 16% are Severe.

Which agencies issued them

101–200 of 608

SevereFDA (Devices)·Z-0352-2023·2022-12-21
Central Venous Catheter Kits Recalled for Potential Connector Housing Failure
ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.
Product
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0445-2023·2022-12-21
Arrow AutoCAT 2 Cardiac Pump Recalled for Potential Battery Runtime Issue
Arrow International is recalling Arrow AutoCAT 2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times.
Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
Category
Medical Device
Distribution
0 states
SevereNHTSA·22V945000·2022-12-21
Volkswagen Recalls 2015-2016 Beetles for Driver Air Bag Defect
Volkswagen is recalling 2015-2016 Beetle and Beetle Convertible vehicles because the driver's side air bag inflator may explode, posing a risk of serious injury or death.
Product
VOLKSWAGEN — VOLKSWAGEN BEETLE, BEETLE CONVERTIBLE
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0442-2023·2022-12-21
Arrow AC3 Optimus IABP Devices Recalled for Short Battery Run-Time Issue
Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.
Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0079-2023·2022-12-21
FDA Recalls Sodium Bicarbonate Injection for Defective Vials
Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0446-2023·2022-12-21
Arrow AutoCAT 2 Cardiac Pump Recalled for Battery Runtime Issues
Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.
Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0451-2023·2022-12-21
FDA Recalls Arrow AutoCAT2WAVE IABP for Short Battery Runtime
The Arrow AutoCAT2WAVE intra-aortic balloon pump is being recalled worldwide due to a potential issue with short battery run-times. Healthcare facilities should contact the manufacturer for guidance.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0454-2023·2022-12-21
Intra-Aortic Balloon Pump Battery Run-Time Issue Recall
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0452-2023·2022-12-21
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Battery Runtime Issues
Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0449-2023·2022-12-21
Intra-Aortic Balloon Pump with Potential Short Battery Run-Times
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pumps are being recalled worldwide due to short battery run-times affecting device operation. Patients using this device should contact their healthcare provider immediately.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0437-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times that could affect the device's ability to provide continuous cardiac support.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0351-2023·2022-12-21
Arrow MAC Two-Lumen Central Venous Access Kit connector housing defect
ARROW INTERNATIONAL is recalling Arrow MAC Two-Lumen Central Venous Access Kits due to potential inadequate connection between the top and bottom housings of included Micro Clave Clear Connectors.
Product
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Category
Medical Device
Distribution
6 states
SevereFDA (Drugs)·D-0080-2023·2022-12-21
FDA Recalls Sodium Bicarbonate Injection Vials for Glass Breakage Risk
Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.
Product
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0086-2023·2022-12-21
Injectable iohexol syringes recalled for mislabeled iodine strength
BayCare Integrated Service Center is recalling 250 iohexol injection syringes mislabeled as 300 mg iodine/mL but actually containing 350 mg iodine/mL. The labeling error could result in dosing mistakes.
Product
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as…
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-0455-2023·2022-12-21
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times
Arrow International is recalling Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices worldwide due to a potential issue with short battery run-times.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0426-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump recalled for short battery run-times
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0456-2023·2022-12-21
Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0432-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump Battery Runtime Recall
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0427-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump: Short Battery Run-Time Issue
Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0433-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Battery Run-Time Issue
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0453-2023·2022-12-21
Intra-Aortic Balloon Pump Recalled for Potential Short Battery Runtime
The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.
Product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0444-2023·2022-12-21
Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall
Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.
Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0430-2023·2022-12-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump short battery run-time issue
Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.
Product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0441-2023·2022-12-21
Arrow AC3 Optimus Intra-Aortic Balloon Pumps recalled for short battery runtime
Arrow International is recalling Arrow AC3 Optimus Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. The pumps may not operate for the intended duration during critical cardiac care.
Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0718-2023·2022-12-21
Siemens allergy test kits recalled for false mold allergen reactivity results
Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.
Product
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0557-2023·2022-12-21
Henry Schein Vas Reversal Pack Surgical Kit Recalled for Incomplete Seal
A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in the US and Canada.
Product
HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0510-2023·2022-12-21
Stradis Medical gynecological surgical kit recalled due to potential sterility breach
Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, GYN PACK, Item No.570-2625
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2023·2022-12-21
Surgical procedure kit recalled due to incompletely sealed outer bag
A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0495-2023·2022-12-21
Dental surgical kits recalled due to incomplete outer bag sealing
Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.
Product
STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0712-2023·2022-12-21
DeRoyal Cataract Pack Surgical Kit Class II Recall
DeRoyal Industries has recalled the DeRoyal CATARACT PACK (368 kits) in a voluntary Class II recall. Affected lot numbers are 55990451 and 56615717 with expiration 08/01/2024.
Product
DeRoyal CATARACT PACK, REF 89-9241.03
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0651-2023·2022-12-21
Medical device shoulder pack recalled by DeRoyal Industries
DeRoyal Industries recalled 48 units of its shoulder pack medical device (Lot 57755295) on November 3, 2022. The specific reason for the recall was not disclosed in available documentation.
Product
DeRoyal SHOULDER PACK, REF 89-9449.13
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0554-2023·2022-12-21
Angio Pack surgical trays recalled for incomplete sealing and sterility breach
Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.
Product
STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0505-2023·2022-12-21
Surgical Pain Tray Outer Bag May Not Be Properly Sealed
Stradis Healthcare is recalling Henry Schein Surgical Pain Trays due to potential incomplete sealing of outer bags, which may compromise sterility. Healthcare providers and facilities should stop using affected trays and contact their supplier for replacement.
Product
HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0515-2023·2022-12-21
Medical and Surgical Procedure Trays Recalled Due to Incomplete Sealing
Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.
Product
HENRY SCHEIN, OMFS, Item No.570-2779,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0529-2023·2022-12-21
Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing
Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0503-2023·2022-12-21
Medical Trays Recalled for Potentially Compromised Sterility from Incomplete Sealing
Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.
Product
HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0692-2023·2022-12-21
FDA Class II Recall of DeRoyal Posterior Spine Surgical Packs
DeRoyal Industries voluntarily recalled 1,196 posterior spine surgical packs distributed across 23 states. The specific reason for the recall was not documented.
Product
DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0655-2023·2022-12-21
DeRoyal Shoulder Kit Subject to FDA Class II Recall
DeRoyal Industries Inc is recalling 14 shoulder kits (Lot 56580884, expiring 12/1/2024) distributed to healthcare facilities in 23 states. The company initiated a voluntary Class II recall with the FDA.
Product
DeRoyal SHOULDER KIT, REF 89-9497.08
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0518-2023·2022-12-21
Medical Procedure Trays Recalled for Potential Sterility Breach
Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.
Product
HENRY SCHEIN, CATH PACK Item No.570-2789
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0502-2023·2022-12-21
Breast Augmentation Trays Recalled Due to Incomplete Packaging Seal
Stradis Medical recalls Henry Schein breast augmentation trays due to incomplete outer bag sealing during manufacturing, which may compromise sterility. The affected kits were distributed nationwide in the US and Canada.
Product
HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0558-2023·2022-12-21
Surgical Procedure Trays Recalled Due to Potentially Compromised Sterility
Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising sterility.
Product
STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0486-2023·2022-12-21
STRADIS HEALTHCARE Oral Surgery Trays Recalled for Potential Sterility Breach
Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.
Product
STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0504-2023·2022-12-21
Surgical Trays Recalled Due to Incomplete Bag Sealing
Stradis Healthcare is recalling surgical trays due to incomplete outer bag sealing that may compromise sterility of the surgical kit.
Product
HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2023·2022-12-21
Stradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal
Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.
Product
STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0591-2023·2022-12-21
DeRoyal procedure packs recalled for containing affected Steri Drapes
DeRoyal Industries is recalling its BASIC NEURO PACK procedure packs because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 96 kits (lot 57287655, expires 9/1/2026) distributed to 23 states.
Product
DeRoyal BASIC NEURO PACK, REF 89-7258.12
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0477-2023·2022-12-21
Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown
Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.
Product
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0473-2023·2022-12-21
BBL Chocolate II Agar laboratory culture media recalled for nutrient deficiency
BBL Chocolate II Agar culture media manufactured by Becton Dickinson contains reduced nutrients and may cause false negative results in laboratory bacterial identification testing.
Product
BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2023·2022-12-21
FDA recalls DeRoyal CRANI PACK medical device over defect
The FDA has recalled DeRoyal CRANI PACK devices (Lot 57389117, expiring 9/1/2026) due to a device defect. The recall affects 16 kits distributed across 23 US states.
Product
DeRoyal CRANI PACK, REF 89-10202.05
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0513-2023·2022-12-21
Medical and surgical procedure trays recalled for incomplete seal
Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.
Product
HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0537-2023·2022-12-21
Stradis Healthcare Phlebectomy Pack Recall Due to Sterility Breach Risk
Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.
Product
STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0715-2023·2022-12-21
DeRoyal Cataract Surgery Packs Recalled for Defective Components
DeRoyal cataract procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The recall includes 520 kits distributed to healthcare facilities.
Product
DeRoyal CATARACT PACK, REF 89-10086.05
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0480-2023·2022-12-21
Ethicon PDS II Surgical Sutures Recalled for Deficient Knot Strength
Ethicon recalls PDS II violet monofilament sutures due to significantly reduced knot tensile strength, posing risk of intra-operative breakage in surgical procedures. The affected lot was distributed internationally to Canada, Japan, Australia, and New Zealand.
Product
PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0680-2023·2022-12-21
FDA recalls 90 DeRoyal pacemaker ICD device packs for defect
DeRoyal Industries is recalling 90 kits of its Pacemaker ICD Pack (Lot 56705350, expiring June 1, 2026) distributed across 23 US states. The specific reason for this voluntary, firm-initiated recall is not disclosed in the FDA notice.
Product
DeRoyal PACEMAKER ICD PACK, REF 89-10216.03
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0684-2023·2022-12-21
DeRoyal Procedure Packs Recalled for Containing Recalled Steri Drapes
DeRoyal CRANI PACK procedure kits are being recalled because they contain 3M Health Care Steri Drapes that were previously recalled. Affected kits were distributed to medical facilities across multiple U.S. states.
Product
DeRoyal CRANI PACK, REF 89-10242.04
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0695-2023·2022-12-21
Hip replacement surgical kits recalled by DeRoyal Industries
DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.
Product
DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0638-2023·2022-12-21
FDA Class II recall of DeRoyal FOOT PACK medical devices
DeRoyal Industries Inc has recalled 350 kits of the DeRoyal FOOT PACK medical device in a Class II FDA recall. The specific reason for the recall was not publicly disclosed in available agency records.
Product
DeRoyal FOOT PACK, REF 89-9252.06
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0703-2023·2022-12-21
FDA Medical Device Recall: DeRoyal Pacemaker ICD Pack
DeRoyal Industries initiated a voluntary recall of its PACEMAKER ICD PACK (Lot 57805969, exp. 11/1/2026). The specific reason for recall is not provided in available source documentation. Affected units were distributed across 23 U.S. states.
Product
DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0544-2023·2022-12-21
Angioplasty Procedure Trays Recalled Due to Incomplete Bag Sealing
Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.
Product
STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0466-2023·2022-12-21
NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates
Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.
Product
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0509-2023·2022-12-21
Surgical Procedure Kits Recalled for Potential Sterility Seal Defect
Stradis Medical is recalling Henry Schein breast procedure kits distributed nationwide in the US and Canada due to incomplete outer bag sealing that may compromise sterility. No illnesses reported.
Product
HENRY SCHEIN, BREAST PACK, Item No.570-2397
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0556-2023·2022-12-21
Surgical Procedure Trays Recalled Over Incomplete Outer Bag Seals
Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.
Product
HENRY SCHEIN, Vas Pack, Item No.888-2520,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0534-2023·2022-12-21
Medical Insertion Tray Recalled for Incomplete Sterile Bag Sealing
Stradis Medical is recalling Henry Schein ILR Insertion Trays due to incomplete outer bag sealing that may compromise sterility. No illnesses have been reported.
Product
HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0546-2023·2022-12-21
Stradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach
Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. Affected units were distributed in the US and Canada.
Product
STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0498-2023·2022-12-21
Stradis Healthcare Cotton Applicator 3 inch kits recalled due to incomplete bag sealing
Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.
Product
STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0567-2023·2022-12-21
DeRoyal Total Knee Procedure Pack Recalled for Defective Steri Drapes
DeRoyal Industries is recalling 79 units of GEO-MED TOTAL KNEE PACK A & B due to defective 3M Steri Drapes included in the procedure packs. The affected units were distributed across 23 states.
Product
GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0561-2023·2022-12-21
DeRoyal Oral Procedure Packs Recalled for Affected Steri Drapes
DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.
Product
DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
Category
Medical Device
Distribution
23 states
HighFDA (Food)·F-0195-2023·2022-12-21
Canned Sardines in Tomato Sauce Recalled Due to Histamine Contamination
St. Jean's Coast Mountain Resources Ltd. is recalling canned Wild Pacific Sardines in tomato sauce due to high histamine levels. The affected product was distributed wholesale to 148 retail customers in the western United States.
Product
Sardines in tomato sauce packed in cans labeled in part, "WILD PACIFIC SARDINES RAINCOAST TRADING TM***IN TOMATO SAUCE***NET. 4.2 oz (120 g)***INGREDIENTS: SARDINES, WATER, TOMATO PASTE, SEA SALT. PRODUCT OF MALAYSIA PACKED FOR: RAINCOAST TRADING, NANAIMO, BC CANADA V9R6Z5***8…
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-0519-2023·2022-12-21
Henry Schein Pacemaker Surgical Kits Recalled for Sterility Concerns
Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.
Product
HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0470-2023·2022-12-21
Zimmer NexGen Stemmed Tibial Components recalled for higher revision rates
Zimmer is voluntarily recalling NexGen Option Stemmed Tibial Component Size 7 (1,049 units) due to higher-than-expected revision rates when used with specific femoral components, based on UK registry data.
Product
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2023·2022-12-21
Stradis Healthcare surgical procedure kits recalled for incomplete outer bag sealing
Stradis Healthcare has recalled surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. Affected units (40 units, lot 22235489419) were distributed across the United States and Canada.
Product
STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0490-2023·2022-12-21
Surgical Procedure Tray Recall Due to Incomplete Packaging Seal
Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses reported.
Product
STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0598-2023·2022-12-21
DeRoyal Spinal Fusion Procedure Packs Recalled for 3M Drape Issue
DeRoyal spinal fusion procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Affected kits were distributed to healthcare facilities across 23 U.S. states.
Product
DeRoyal SPINAL FUSION PACK, REF 89-7515.14
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0521-2023·2022-12-21
Medical and surgical procedure kits recalled for potential sterility loss
Stradis Medical is recalling Henry Schein Basic Extended Pack procedure kits due to incomplete sealing of the outer bag, which may compromise sterility. Products were distributed in the US and Canada.
Product
HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0501-2023·2022-12-21
Stradis Healthcare surgical procedure trays recalled for incomplete packaging seals
Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide in the US and Canada.
Product
STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0469-2023·2022-12-21
Zimmer NexGen Option Stemmed Tibial Component Voluntary Recall Due to Higher Revision Rates
Zimmer is recalling NexGen Option Stemmed Tibial Components due to clinically significant higher revision rates when used with specific femoral components. Patients should contact their surgeon to discuss their implant.
Product
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2023·2022-12-21
Stradis Healthcare Medical Vein Kits Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Medical Vein procedure kits due to potentially incomplete sealing of the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
Product
STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0482-2023·2022-12-21
Oral Surgery Tray Kit Recalled for Potential Sterility Breach
ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.
Product
ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0565-2023·2022-12-21
DeRoyal Surgical Procedure Packs Recalled Due to Defective Steri Drapes
DeRoyal is recalling procedure packs containing recalled 3M Steri Drapes. Affected lot 56181816 (exp. 10/1/2023) distributed across multiple U.S. states.
Product
DeRoyal PEDI ORTHO PACK, REF 89-5323.20
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0532-2023·2022-12-21
FDA recalls Henry Schein bone marrow kit for defective seal
Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.
Product
HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0528-2023·2022-12-21
Medical Procedure Trays Recalled for Incomplete Outer Bag Sealing
Stradis Healthcare recalls Henry Schein Rhino Pack surgical trays due to potentially incomplete outer bag sealing that may compromise kit sterility. The recall affects 328 units distributed in the US and Canada.
Product
HENRY SCHEIN, RHINO PACK, Item No.570-3070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0552-2023·2022-12-21
Surgical Procedure Kits Recalled for Incomplete Outer Bag Seal
Stradis Healthcare is recalling Varicosity Basic Pack surgical procedure kits (105 units) distributed in the US and Canada due to potentially incomplete outer bag sealing that may compromise sterility.
Product
STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2023·2022-12-21
Medical Device: DeRoyal HEART B PACK Recalled by FDA
DeRoyal Industries initiated a Class II recall of its HEART B PACK medical device kit affecting 68 units distributed across 23 US states (Lot 56613762, expires 6/1/2026). The specific reason for recall is not available in source documentation.
Product
DeRoyal KIT HEART B PACK, REF 89-9042.07
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0562-2023·2022-12-21
DeRoyal Procedure Packs Recalled Due to Included 3M Steri Drapes
DeRoyal Industries recalls EYE PACK procedure kits because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 156 kits distributed across 23 U.S. states.
Product
DeRoyal EYE PACK, REF 89-4051.09
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0555-2023·2022-12-21
Surgical procedure trays recalled due to incomplete outer bag sealing
Stradis Healthcare is recalling surgical procedure trays that may have incompletely sealed outer bags, risking sterility breach. Sixteen units were distributed nationwide and in Canada.
Product
STRADIS HEALTHCARE, Breast, Item No.693-276,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0500-2023·2022-12-21
Stradis Healthcare Introducer Kit Micro recalled for potential sterility compromise
Stradis Healthcare is recalling 180 units of its Introducer Kit Micro cardiovascular devices due to potential incomplete sealing of outer bags that may compromise sterility.
Product
STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0483-2023·2022-12-21
Surgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect
Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.
Product
STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0717-2023·2022-12-21
Diagnostic Kit Recall: Falsely Elevated Mold Allergen Test Results
Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.
Product
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0549-2023·2022-12-21
Endovenous Procedure Packs Recalled for Incomplete Bag Sealing
Stradis Healthcare is recalling Endovenous Packs due to incompletely sealed outer bags that may compromise kit sterility. No illnesses have been reported.
Product
www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2023·2022-12-21
Surgical dental procedure kits recalled due to incomplete bag sealing
Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.
Product
STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0627-2023·2022-12-21
DeRoyal Total Hip surgical procedure kit recall due to defective components
DeRoyal is recalling 146 surgical procedure kits containing recalled 3M Steri Drapes. The kits were distributed to medical facilities in 23 US states.
Product
DeRoyal KIT TOTAL HIP, REF 89-8861.07
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0540-2023·2022-12-21
Surgical Procedure Trays with Potentially Compromised Sterile Packaging
Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide in the US and Canada.
Product
STRADIS HEALTHCARE, Phleb, Item No.682-1425,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0550-2023·2022-12-21
Stradis Healthcare Endo Pack Surgical Trays Recalled for Incomplete Seal
Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.
Product
STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0711-2023·2022-12-21
DeRoyal surgical cataract pack subject to Class II recall
DeRoyal Industries voluntarily recalled 530 cataract surgical packs (Lot 57755800) classified as FDA Class II. The recall affects multiple U.S. states.
Product
DeRoyal CATARACT PACK, REF 89-8859.08
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0481-2023·2022-12-21
STRADIS HEALTHCARE Eye Surgical Kits Recalled for Incomplete Sealing
STRADIS HEALTHCARE WECKCELL EYE SPEARS surgical kits (Item 9430, 9431) are recalled due to incomplete outer bag sealing that may compromise kit sterility. Approximately 80 kits distributed in the US and Canada are affected.
Product
STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2023·2022-12-21
Oncentra Brachy Radiation Therapy Software Reconstruction Error
Elekta's Oncentra Brachy radiation therapy planning software may experience reconstruction errors when using Catheter Bending functionality in versions 4.0 and above.
Product
Oncentra Brachy radiation therapy planning system software.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0522-2023·2022-12-21
Surgical Procedure Trays Recalled for Incomplete Sterile Barrier Sealing
Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.
Product
HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0581-2023·2022-12-21
DeRoyal Cannulated Hip Packs Recalled for Defective Steri Drapes
DeRoyal Industries is recalling 108 kits of Cannulated Hip Procedure Packs because they contain 3M Steri Drapes that have been recalled. Affected lots were distributed across 23 U.S. states.
Product
DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0609-2023·2022-12-21
DeRoyal HEART PACK procedure kits recalled for defective component
DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.
Product
DeRoyal HEART PACK, REF 89-8351.12
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-0553-2023·2022-12-21
STRADIS HEALTHCARE Surgical Procedure Trays Recalled for Incomplete Sterile Sealing
STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, potentially compromising kit sterility.
Product
STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0487-2023·2022-12-21
Oral Surgery Trays Recalled for Incomplete Sealing of Sterility Bags
Stradis Healthcare is recalling certain oral surgery trays because the outer packaging may be incompletely sealed, potentially compromising the sterility of the surgical instruments.
Product
STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide

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